Kidney StoneNCT03999255
SEARCH FOR OPTIMAL ANAESTHESIA IN RETROGRADE INTRARENAL SURGERY
A study testing combined respiratory support (CRS) in people with Kidney Stone, run by St. Petersburg State Pavlov Medical University at 1 site in Russia.
Trial summary
Patients undergoing retrograde intrarenal surgery for kidney stones from November 2017 to May 2018 were prospectively recruited to participate in the study. In each case after the beginning of general anesthesia with mechanical ventilation surgeons were asked to assess the mobility of the operative field and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Stone
- What is being tested?
- combined respiratory support (CRS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteRussia
- Study dates
- 1 Nov 2017to 1 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Kidneys stones with indications for retrograde intrarenal surgery
Who cannot join
- Patients with ASA class of greater than 3
- Patients with active urinary tract infection were excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: REDUCING KIDNEY MOTION: OPTIMIZING ANESTHESIA AND COMBINING RESPIRATORY SUPPORT FOR RETROGRADE INTRARENAL SURGERY: A PILOT STUDY
Patients undergoing retrograde intrarenal surgery for kidney stones from November 2017 to May 2018 were prospectively recruited to participate in the study. In each case after the beginning of general anesthesia with mechanical ventilation surgeons were asked to assess the mobility of the operative field and conditions for laser lithotripsy according to the developed questionnaire scale. The questionnaire consisted of 5 degrees of assessment of kidney mobility and each question was scored from 1 to 5, 1 being very mobile (extremely poor conditions for dusting) and 5 completely immobile (Ideal conditions for dusting). After this assessment modified technique of general anesthesia was applied called combined respiratory support which consisted of reduction of tidal volume to 250-300 ml and respiratory rate to 4-5 per minute with transcatheter high frequency jet ventilation through endotracheal tube with a respiratory cycle frequency of 300 per minute and maintained during retrograde intrarenal surgery. At the beginning of combined respiratory approach, surgeons were once again asked to assess the mobility of the operative field and the conditions for laser lithotripsy. Main ventilation parameters were recorded and compared in both regimens.
- Conditions
- Kidney Stone
- Being tested
- combined respiratory support (CRS)
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined respiratory support (CRS)Procedure or surgery
combined respiratory support (CRS) which consisted of reduction of tidal volume to 250-300 ml and respiratory rate to 4-5 per minute with transcatheter high-frequency jet ventilation (HFJV) through an endotracheal tube with a respiratory cycle frequency (RCF) of 300 per minute and maintained during RIRS.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing intrarenal surgery | Experimental | Not described Receives: Procedure: combined respiratory support (CRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kidney motion assessed by the endourologist during retrograde intrarenal surgery
a questionnaire was implemented in order to assess surgeon's feedback on novel technique. This was done in 2-step fashion in every patient and each patient served his own control: first, after the beginning of GA with MV in the mode of normal ventilation the questionnaire was implemented and surgeons were asked to assess the mobility of the operative field and the decency of conditions for laser lithotripsy.
Second, novel CRS technique was then instituted and maintained throughout RIRS. Before lithotripsy itself surgeons were once again asked to assess the mobility of the operative field and conditions for laser lithotripsy according to the previously mentioned questionnaire.
Measured: duration of RIRS Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start1 Nov 2017
- Primary completion3 Mar 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Petersburg State Pavlov Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nariman.gadjiev, St. Petersburg State Pavlov Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999255
- Sponsor's protocol ID
- №3/18
- Status last verified
- Jun 2019
- First submitted
- 23 Jun 2019
- Last updated
- 26 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gadzhiev N, Oibolatov U, Kolotilov L, Parvanyan S, Akopyan G, Petrov S, Cottone CM, Sung J, Okhunov Z. Reducing kidney motion: optimizing anesthesia and combining respiratory support for retrograde intrarenal surgery: a pilot study. BMC Urol. 2019 Jul 5;19(1):61. doi: 10.1186/s12894-019-0491-3.
PubMed 31277626
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REDUCING KIDNEY MOTION: OPTIMIZING ANESTHESIA AND COMBINING RESPIRATORY SUPPORT FOR RETROGRADE INTRARENAL SURGERY: A PILOT STUDY
- ClinicalTrials.gov ID
- NCT03999255
- Acronym / sponsor ID
- №3/18
- Conditions
- Kidney Stone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- St. Petersburg State Pavlov Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 3 Mar 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 26 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients undergoing retrograde intrarenal surgery for kidney stones from November 2017 to May 2018 were prospectively recruited to participate in the study. In each case after the beginning of general anesthesia with mechanical ventilation surgeons were asked to assess the mobility of the operative field and conditions for laser lithotripsy according to the developed questionnaire scale. The questionnaire consisted of 5 degrees of assessment of kidney mobility and each question was scored from 1 to 5, 1 being very mobile (extremely poor conditions for dusting) and 5 completely immobile (Ideal conditions for dusting). After this assessment modified technique of general anesthesia was applied called combined respiratory support which consisted of reduction of tidal volume to 250-300 ml and respiratory rate to 4-5 per minute with transcatheter high frequency jet ventilation through endotracheal tube with a respiratory cycle frequency of 300 per minute and maintained during retrograde intrarenal surgery. At the beginning of combined respiratory approach, surgeons were once again asked to assess the mobility of the operative field and the conditions for laser lithotripsy. Main ventilation parameters were recorded and compared in both regimens.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing intrarenal surgery | Experimental | Procedure: combined respiratory support (CRS) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Kidneys stones with indications for retrograde intrarenal surgery
Key exclusion criteria (2 listed)
- Patients with ASA class of greater than 3
- Patients with active urinary tract infection were excluded from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| combined respiratory support (CRS)combined respiratory support (CRS) which consisted of reduction of tidal volume to 250-300 ml and respiratory rate to 4-5 per minute with transcatheter high-frequency jet ventilation (HFJV) through an endotracheal tube with a respiratory cycle frequency (RCF) of 300 per minute and maintained during RIRS. | Procedure or surgery | Patients undergoing intrarenal surgery |
Primary outcome
Kidney motion assessed by the endourologist during retrograde intrarenal surgery
Time frame: duration of RIRS Surgery
a questionnaire was implemented in order to assess surgeon's feedback on novel technique. This was done in 2-step fashion in every patient and each patient served his own control: first, after the beginning of GA with MV in the mode of normal ventilation the questionnaire was implemented and surgeons were asked to assess the mobility of the operative field and the decency of conditions for laser lithotripsy. Second, novel CRS technique was then instituted and maintained throughout RIRS. Before lithotripsy itself surgeons were once again asked to assess the mobility of the operative field and conditions for laser lithotripsy according to the previously mentioned questionnaire.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2019.
- Derived from this study: PubMed 31277626Gadzhiev N, Oibolatov U, Kolotilov L, Parvanyan S, Akopyan G, Petrov S, Cottone CM, Sung J, Okhunov Z. Reducing kidney motion: optimizing anesthesia and combining respiratory support for retrograde intrarenal surgery: a pilot study. BMC Urol. 2019 Jul 5;19(1):61. doi: 10.1186/s12894-019-0491-3.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combined respiratory support (CRS) in people with Kidney Stone, run by St. Petersburg State Pavlov Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kidney motion assessed by the endourologist during retrograde intrarenal surgery (time frame: duration of RIRS Surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03999255, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2019.